QA Specialist

Job Description

QA Specialist - A leading pharmaceutical company is seeking to attract an experienced QA professional. if you are interested in this or alternative QA roles apply below

QA Specialist/ RP - Pharmaceutical - Cork

Key Role Activities:

• Prepare, update and approve procedures in accordance with GMP/GDP and company requirements
• Manage all documents in accordance with records management
• Assist in the implementation and update of internal or external standards
• Identify and Log Quality Issues, perform impact assessments and lead investigations
• Collaborate effectively with various internal and external partners
• Ensure appropriate management of non-conformances related to GMP and GDP, internal and external change controls and CAPAs.
• Support the Quality Manager with monitoring and oversight of outsourced activities.
• Perform allocated internal audits as required
• Support and participate in local initiatives or projects to increase compliance and reduce costs/non-conformance.
• Provide the necessary input to the Quality Manager for the bi-annual management review of the Legal Entities.
• Support the process for intake of medicinal queries and complaints, ensuring timely case processing.

The role profile of the Quality Executive/Deputy Responsible Person is to act in accordance with the requirements detailed below in the absence of the RP, ensuring to keep appropriate records of any delegated duties.

• Maintains the Wholesale Distribution Authorisation, ensuring compliance with the general conditions detailed, in line with European and local regulations.
• To ensure compliance with the requirements of Good Distribution Practice (EU GDP).
• To ensure that all aspects of the quality system are implemented and maintained.
• Ensure that the quality, safety and traceability of medicinal products are maintained within the supply chain.
• To ensure appropriate competence and experience as well as knowledge of and training in GDP.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.